Medline Medical Procedure Kits Recalled for Higher Endotoxin Levels
Medline Industries is recalling medical procedure kits containing neuro sponges worldwide because testing found higher-than-expected endotoxin levels, indicating products may be out-of-specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving medical devices (neuro sponges) with a high-risk hazard (endotoxin contamination). No illnesses or injuries are explicitly reported in the source text, but endotoxin is a serious hazard for sterile surgical products where contamination poses risk of harm if the devices are used in procedures.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges. The recall affects approximately 9,805 kits distributed worldwide. The kits included in this recall are: NEURO BASIN PACK-LF (SKUs DYNJ0532910L and DYNJ39461J), PK-MAD SPINE (SKUs DYNJ58060I and DYNJ58060J), NEURO BASIN KIT (SKU DYNJ80200B), NEURO-SPINE BASIN PACK (SKU DYNJ83019), ENT PACK (SKUs DYNJ86328, DYNJ89675, and DYNJ89675A), EDMOND SPINE PACK (SKU DYNJ89263), and ENT/PAIN PACK (SKU DYNJT7493).
During an internal review, Medline identified higher-than-endotoxin levels on a representative neuro sponge product. This indicates that in-market products may be out-of-specification for endotoxin. Endotoxins are bacterial contaminants that can cause adverse reactions in medical applications.
Consumers and healthcare facilities that have received these kits should stop using them and contact Medline Industries for instructions on return or replacement. Healthcare providers should review patient records to determine if any of the recalled kits were used in procedures. Specific lot numbers and UDI codes are available through the FDA recall notice for product identification.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPI
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin
- bacterial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline Kit Number/SKU DYNJ0532910L: UDI/DI each 10198459503870
- UDI/DI case 40198459503871
- Lot Number: 25IMD003
- Lot Number: 25HMH643
- Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721
- UDI/DI case 40195327112722
- Lot Number: 22GBS127
- Lot Number: 22FBB472
- Lot Number: 25FBE752
- Lot Number: 25EBA260
- Lot Number: 25DBG176
- Lot Number: 25CBD819
- Lot Number: 25BBA593
- Lot Number: 24KBJ163
- Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159
- UDI/DI case 40195327326150
- Lot Number: 23KMI415
- Lot Number: 23JMK023
- Lot Number: 23JMB211
- Lot Number: 23IMC591
Distribution
Distribution scope not specified by the agency.
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